38 | 64 | | |
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39 | 65 | | An Act relating to the practice of pharmacy; allowing |
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40 | 66 | | pharmacist to test or screen for and initiate drug |
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41 | 67 | | therapy for minor, nonchronic h ealth conditions; |
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42 | 68 | | specifying allowed tests; allowing pharmacist to |
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43 | 69 | | dispense certain products under certain protocol; |
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44 | 70 | | directing promulgation of rules; amending 59 O.S. |
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45 | 71 | | 2021, Section 353.1, as amended by Sect ion 6, Chapter |
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46 | 72 | | 288, O.S.L. 2022 (59 O.S. Supp. 202 3, Section 353.1), |
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47 | 73 | | which relates to definitions used in the Oklahoma |
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48 | 74 | | Pharmacy Act; modifying and adding definitions; |
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49 | 75 | | updating statutory language and references; providing |
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50 | 76 | | for codification; providing an effective date; and |
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51 | 77 | | declaring an emergency . |
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52 | 78 | | |
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53 | 79 | | |
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54 | 80 | | |
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55 | 81 | | |
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56 | 82 | | |
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57 | 83 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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58 | 84 | | SECTION 1. NEW LAW A new section of law to be codified |
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59 | 85 | | in the Oklahoma Statutes as Section 353.31 of Title 59, unless there |
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60 | 86 | | is created a duplication i n numbering, reads as fol lows: |
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61 | 87 | | A. A pharmacist may test or screen for a nd initiate drug |
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62 | 88 | | therapy for minor, nonchronic health conditions as defined in |
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63 | 89 | | Section 353.1 of Title 59 of the Oklahoma Stat utes. |
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94 | 144 | | 1. Approved by, cleared by, or authorized under an emergency |
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95 | 145 | | use authorization by the United States Food and Drug Administration; |
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96 | 146 | | and |
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97 | 147 | | 2. Waived under the federal C linical Laboratory Improvement |
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98 | 148 | | Amendments of 1988 (CLIA) or deemed to be CLIA-waived for use in |
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99 | 149 | | patient care settings operating under a CLIA certificate. |
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100 | 150 | | C. A pharmacist may dispense self-administered hormonal |
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101 | 151 | | contraceptives under the protocol es tablished pursuant to subsection |
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102 | 152 | | D of this section, regardless of whether the patient has obtained a |
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103 | 153 | | prescription. |
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104 | 154 | | D. The State Board of Pharmacy shall adopt rules establishing a |
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105 | 155 | | protocol for dispensing self-administered hormonal contraceptives by |
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106 | 156 | | January 1, 2025. |
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107 | 157 | | SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.1, as |
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108 | 158 | | amended by Section 6, Chapter 288, O.S.L. 2022 (5 9 O.S. Supp. 2023, |
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109 | 159 | | Section 353.1), is amended to read as follows: |
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110 | 160 | | Section 353.1. For the purposes of the Oklahoma Pharmacy Act: |
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111 | 161 | | 1. “Accredited program” means those seminars, classes, |
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112 | 162 | | meetings, work projects, and oth er educational courses approved by |
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113 | 163 | | the Board State Board of Pharmacy for purposes of continuing |
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114 | 164 | | professional education; |
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143 | 217 | | 3. “Administer” means the direct application of a drug, whether |
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144 | 218 | | by injection, inhalation, in gestion, or any other means, to the body |
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145 | 219 | | of a patient; |
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146 | 220 | | 4. “Assistant pharmacist” means any person presently licensed |
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147 | 221 | | as an assistant pharmacist in the State of Oklahom a this state by |
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148 | 222 | | the Board pursuant to Section 353.10 of this title and for the |
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149 | 223 | | purposes of the Okla homa Pharmacy Act shal l be considered the same |
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150 | 224 | | as a pharmacist, except where otherwise specified; |
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151 | 225 | | 5. “Board” or “State Board” means the State Board of Pharmacy; |
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152 | 226 | | 6. “Certify” or “certification of a prescription ” means the |
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153 | 227 | | review of a filled pre scription by a licensed pharmac ist or a |
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154 | 228 | | licensed practitioner with dispensing authority to confirm that the |
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155 | 229 | | medication, labeling, and packaging of the filled prescription are |
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156 | 230 | | accurate and meet all requirements prescribed by state and federal |
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157 | 231 | | law. For the purposes of this paragraph, “licensed practitioner” |
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158 | 232 | | shall not include optometrists with dispensing authority; |
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159 | 233 | | 7. “Chemical” means any medicinal substance, whether simple or |
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160 | 234 | | compound or obtained through the process of the science and art of |
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161 | 235 | | chemistry, whether of organic or inorganic origin; |
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162 | 236 | | 8. “Compounding” means the combining, admixing, mixing, |
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163 | 237 | | diluting, pooling, reconstituting, or otherwise altering of a drug |
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164 | 238 | | or bulk drug substance to create a drug. Compounding includes the |
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194 | 292 | | 9. “Continuing professional education” means professional, |
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195 | 293 | | pharmaceutical education in the general areas of the socioeconomic |
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196 | 294 | | and legal aspects of he alth care; the properties and actions of |
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197 | 295 | | drugs and dosage forms; and the etiology, characteristics, and |
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198 | 296 | | therapeutics of the diseased state; |
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199 | 297 | | 10. “Dangerous drug”, “legend drug”, “prescription drug”, or |
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200 | 298 | | “Rx Only” means a drug: |
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201 | 299 | | a. for human use subject to 21 U.S.C. 353(b)( 1), or |
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202 | 300 | | b. is labeled “Prescription Only”, or labeled with the |
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203 | 301 | | following statement: “Caution: Federal law restricts |
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204 | 302 | | this drug except for to use by or on the order of a |
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205 | 303 | | licensed veterinarian.”; |
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206 | 304 | | 11. “Director” means the Executive Director of the State Board |
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207 | 305 | | of Pharmacy unless context clearly indi cates otherwise; |
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208 | 306 | | 12. “Dispense” or “dispensing” means the interpretation, |
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209 | 307 | | evaluation, and implementation of a prescription drug order |
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210 | 308 | | including the preparation and delivery of a drug or device to a |
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211 | 309 | | patient or a patient’s agent in a suitable container appr opriately |
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212 | 310 | | labeled for subsequent administration to, or use by, a patient. |
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213 | 311 | | Dispense includes sell, distribute, leave with, give away, dispose |
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214 | 312 | | of, deliver, or supply; |
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245 | 367 | | by law to dispense or administer prescription drugs, and the |
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246 | 368 | | affiliated warehouses or distributions of such entities under common |
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247 | 369 | | ownership and control that do not act as a wholesale distributor. |
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248 | 370 | | For the purposes of this paragraph, “dispenser” dispenser does not |
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249 | 371 | | mean a person who dispenses only products to be used in animals in |
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250 | 372 | | accordance with 21 U.S.C. 360b(a)(5); |
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251 | 373 | | 14. “Distribute” or “distribution” means the sale, purchase, |
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252 | 374 | | trade, delivery, handling, storage, or receipt of a product, and |
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253 | 375 | | does not include the dispensing of a product pursuant to a |
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254 | 376 | | prescription executed in accordance with 21 U.S.C. 353(b)(1) or the |
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255 | 377 | | dispensing of a product approved under 21 U.S.C. 360b(b); provided, |
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256 | 378 | | taking actual physical possession of a product or title shall not be |
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257 | 379 | | required; |
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258 | 380 | | 15. “Doctor of Pharmacy” means a person licensed by the Board |
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259 | 381 | | to engage in the practice of pharmacy. The terms “pharmacist”, |
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260 | 382 | | “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and s hall |
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261 | 383 | | have the same meaning wherever they appear in the Oklahoma Statutes |
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262 | 384 | | and the rules promulgated by the Board; |
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263 | 385 | | 16. “Drug outlet” means all manufacturers, repackagers, |
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264 | 386 | | outsourcing faciliti es, wholesale distributors, third-party |
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265 | 387 | | logistics providers, pharm acies, and all other facilities which are |
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295 | 441 | | 17. “Drugs” means all medicinal s ubstances and preparations |
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296 | 442 | | recognized by the United States Pharmacopoeia Pharmacopeia and |
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297 | 443 | | National Formulary, or any revision thereof, and all substances and |
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298 | 444 | | preparations intended for external and/or internal use in the cure, |
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299 | 445 | | diagnosis, mitigation, treatment , or prevention of disease in humans |
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300 | 446 | | or animals and all substances and preparations, other than food, |
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301 | 447 | | intended to affect the structure or any function of the body of a |
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302 | 448 | | human or animals; |
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303 | 449 | | 18. “Drug sample” means a unit of a prescription drug packaged |
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304 | 450 | | under the authority and responsibility of th e manufacturer that is |
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305 | 451 | | not intended to be sold and is intended to promote the sale of the |
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306 | 452 | | drug; |
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307 | 453 | | 19. “Durable medical equipment” has the same meaning as |
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308 | 454 | | provided by Section 2 of this act 375.2 of this title; |
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309 | 455 | | 20. “Filled prescription” means a packaged pres cription |
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310 | 456 | | medication to which a label has been affixed which con tains such |
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311 | 457 | | information as is required by the Oklahoma Pharmacy Act; |
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312 | 458 | | 21. “Hospital” means any institution licensed as a hospital by |
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313 | 459 | | this state for the ca re and treatment of patients, or a pharm acy |
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314 | 460 | | operated by the Oklahoma Department of Veterans Affairs; |
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315 | 461 | | 22. “Licensed practitioner” means an allopathic physician, |
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316 | 462 | | osteopathic physician, podiatric physician, dentist, veterinarian, |
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346 | 516 | | 23. “Manufacturer” or “virtual manufacturer” means with respect |
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347 | 517 | | to a product: |
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348 | 518 | | a. a person that holds an application approved under 21 |
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349 | 519 | | U.S.C. 355 or a license issued under 42 U.S.C. 262 for |
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350 | 520 | | such product, or if such product is not the subject of |
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351 | 521 | | an approved application or license, the person who |
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352 | 522 | | manufactured the product, |
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353 | 523 | | b. a co-licensed partner of the person described in |
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354 | 524 | | subparagraph a of this paragraph that obtains the |
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355 | 525 | | product directly from a person described in this |
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356 | 526 | | subparagraph or subparagraph a of this paragraph, |
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357 | 527 | | c. an affiliate of a person described in subparagraph a |
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358 | 528 | | or b of this paragraph who receives the product |
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359 | 529 | | directly from a person described in this subparagraph |
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360 | 530 | | or in subparagraph a or b of this paragraph, or |
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361 | 531 | | d. a person who contracts with another to manufacture a |
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362 | 532 | | product; |
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363 | 533 | | 24. “Manufacturing” means the production, preparation, |
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364 | 534 | | propagation, compounding, conversion, or processing of a device or a |
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365 | 535 | | drug, either directly or indirectly by extraction from substances of |
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366 | 536 | | natural origin or independently by means of chemical or biological |
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367 | 537 | | synthesis and includes any pac kaging or repackaging of the |
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397 | 591 | | “manufacturing” manufacturing also includes the preparation and |
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398 | 592 | | promotion of commercially avail able products from bul k compounds for |
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399 | 593 | | resale by licensed pharmacies, licensed practitioners, or other |
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400 | 594 | | persons; |
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401 | 595 | | 25. “Medical gas” means those gases including those in liquid |
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402 | 596 | | state upon which the manufacturer or distributor has placed one of |
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403 | 597 | | several cautions, such as “Rx Only”, in compliance with federal l aw; |
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404 | 598 | | 26. “Medical gas order” means an order for medical gas issued |
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405 | 599 | | by a licensed prescriber; |
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406 | 600 | | 27. “Medical gas distributor” means a person licensed to |
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407 | 601 | | distribute, transfer, wholesale, deliver, or sell medical gases on |
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408 | 602 | | drug orders to suppliers or oth er entities licensed to use, |
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409 | 603 | | administer, or distribute medical gas and may also include a patient |
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410 | 604 | | or ultimate user; |
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411 | 605 | | 28. “Medical gas supplier” means a person who disp enses medical |
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412 | 606 | | gases on drug orders only to a pati ent or ultimate user; |
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413 | 607 | | 29. “Medicine” means any drug or combination of drugs which has |
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414 | 608 | | the property of curing, preventing, treating, diagnosing, or |
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415 | 609 | | mitigating diseases, or which is used for that purpose; |
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416 | 610 | | 30. “Minor, nonchronic health condition” means a typically |
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417 | 611 | | short-term health condition that is generally m anaged with |
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448 | 666 | | b. streptococcus, |
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449 | 667 | | c. SARS-CoV-2, |
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450 | 668 | | d. lice, and |
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451 | 669 | | e. other emerging and existing pub lic health threats |
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452 | 670 | | identified by the State Department of Health if |
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453 | 671 | | permitted by an order, rule, or regulation; |
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454 | 672 | | 31. “Nonprescription drugs” means medicines or drug s which are |
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455 | 673 | | sold without a prescription and which are prepackaged for use by the |
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456 | 674 | | consumer and labeled in accordance with the requirements of the |
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457 | 675 | | statutes and regulations of this state and the federal gov ernment. |
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458 | 676 | | Such items shall also include medical and d ental supplies and |
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459 | 677 | | bottled or nonbulk chemicals which are sold or offered for sale to |
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460 | 678 | | the general public if such articles or preparations meet the |
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461 | 679 | | requirements of the Federal Food, Drug, and Cosmetic Act, 21 |
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462 | 680 | | U.S.C.A., Section 321 et seq.; |
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463 | 681 | | 31. 32. “Outsourcing facility” including “virtual outsourcing |
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464 | 682 | | facility” means a facility at one geographic location or address |
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465 | 683 | | that: |
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466 | 684 | | a. is engaged in the compounding of sterile drugs, |
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467 | 685 | | b. has elected to register as an outsourcing facility, |
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468 | 686 | | and |
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499 | 741 | | intended by the manufacturer for ultimate sale to the dispenser of |
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500 | 742 | | such product. For the purposes of this paragraph, “individual |
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501 | 743 | | saleable unit” means the smallest container of a product introduced |
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502 | 744 | | into commerce by the manufacturer or repackager that is intended by |
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503 | 745 | | the manufacturer or repackager for individual sale to a dispenser; |
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504 | 746 | | 33. 34. “Person” means an individual, partnership, limited |
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505 | 747 | | liability company, corporation, or association, unless the context |
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506 | 748 | | otherwise requires; |
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507 | 749 | | 34. 35. “Pharmacist-in-charge” or “PIC” means the pharmacist |
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508 | 750 | | licensed in this state responsible for the management control of a |
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509 | 751 | | pharmacy and all other aspects of the practice of pharmacy in a |
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510 | 752 | | licensed pharmacy as defined by Section 353.18 of this title; |
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511 | 753 | | 35. 36. “Pharmacy” means a place regularly licensed by the |
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512 | 754 | | State Board of Pharmacy in which prescriptions, drugs, medicines, |
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513 | 755 | | chemicals, and poisons are compounded or dispensed or such place |
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514 | 756 | | where pharmacists practice the profession of pharmacy, or a pharmacy |
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515 | 757 | | operated by the Oklahoma Department of Veterans Affairs; |
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516 | 758 | | 36. 37. “Pharmacy technician”, “technician”, “Rx tech”, or |
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517 | 759 | | “tech” means a person issued a Technician technician permit by the |
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518 | 760 | | State Board of Pharmacy to assist the pharmacist and perform |
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519 | 761 | | nonjudgmental, technical, manipulative, non-discretionary functions |
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549 | 815 | | 37. 38. “Poison” means any substance which when introduced into |
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550 | 816 | | the body, either directly or by absorption, produces violent, |
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551 | 817 | | morbid, or fatal changes, or which destroys living tissue with which |
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552 | 818 | | such substance comes into contact; |
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553 | 819 | | 38. 39. “Practice of pharmacy” means: |
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554 | 820 | | a. the interpretation and evaluation of prescription |
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555 | 821 | | orders, |
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556 | 822 | | b. the compounding, dispensing, administering, and |
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557 | 823 | | labeling of drugs and devices, except labeling by a |
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558 | 824 | | manufacturer, repackager, or distributor of |
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559 | 825 | | nonprescription drugs a nd commercially packaged legend |
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560 | 826 | | drugs and devices, |
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561 | 827 | | c. the participation in drug selection and drug |
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562 | 828 | | utilization reviews, |
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563 | 829 | | d. the proper and safe storage of drugs and devices and |
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564 | 830 | | the maintenance of proper records thereof, |
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565 | 831 | | e. the responsibility for advising by counseling and |
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566 | 832 | | providing information, where professionally necessary |
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567 | 833 | | or where regulated, of therapeutic values, content, |
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568 | 834 | | hazards, and use of drugs and devices, |
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599 | 889 | | g. the ordering, performing, and interpreting of tests |
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600 | 890 | | for minor, nonchronic health conditio ns that meet the |
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601 | 891 | | requirements of Section 1 of this act and the |
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602 | 892 | | initiation of drug therapy for minor, nonchronic |
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603 | 893 | | health conditions, |
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604 | 894 | | h. the dispensing of se lf-administered hormonal |
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605 | 895 | | contraceptives as provided by Section 1 of this act, |
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606 | 896 | | or |
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607 | 897 | | i. the provision of those acts or services that are |
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608 | 898 | | necessary to provide pharmaceutical care; |
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609 | 899 | | 39. 40. “Preparation” means an article which may or may not |
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610 | 900 | | contain sterile produc ts compounded in a licensed pharmacy pursuant |
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611 | 901 | | to the order of a licensed prescriber; |
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612 | 902 | | 40. 41. “Prescriber” means a person licensed in this state who |
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613 | 903 | | is authorized to prescribe dangerous drugs within the scope of |
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614 | 904 | | practice of the person’s profession; |
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615 | 905 | | 41. 42. “Prescription” means and includes any order for drug or |
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616 | 906 | | medical supplies written or signed, or transmitted by word of mouth, |
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617 | 907 | | telephone, or other means of co mmunication: |
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618 | 908 | | a. by a licensed prescriber, |
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650 | 964 | | c. by an Oklahoma licensed wholesaler or distributor as |
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651 | 965 | | authorized in Section 353.29.1 of this title; |
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652 | 966 | | 42. 43. “Product” means a prescription drug in a f inished |
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653 | 967 | | dosage form for administration to a patient w ithout substantial |
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654 | 968 | | further manufacturing, such as ca psules, tablets, and lyophilized |
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655 | 969 | | products before reconstitution. “Product” Product does not include |
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656 | 970 | | blood components intended for transfusion, radioactive drugs or |
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657 | 971 | | biologics and medical gas; |
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658 | 972 | | 43. 44. “Repackager”, including “virtual repackager”, means a |
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659 | 973 | | person who owns or operates an establishment that repacks and |
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660 | 974 | | relabels a product or package for further sale or distribution |
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661 | 975 | | without further transaction; |
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662 | 976 | | 44. 45. “Sterile drug” means a drug that is intended for |
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663 | 977 | | parenteral administration, an ophthalmic or oral inhalation drug in |
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664 | 978 | | aqueous format, or a drug that is required to be sterile under state |
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665 | 979 | | and federal law; |
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666 | 980 | | 45. 46. “Supervising physician” means an individual holding a |
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667 | 981 | | current license to practice as a physician from the State Board of |
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668 | 982 | | Medical Licensure and Supervision, pursuant to the provisions of the |
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669 | 983 | | Oklahoma Allopathic Medical and Surgical Licensure and Supervision |
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701 | 1039 | | training as an intern, resident, or fellow . To be eligible to |
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702 | 1040 | | supervise an advanced practice registered nurse Advanced Practice |
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703 | 1041 | | Registered Nurse, such physician shall remain in compliance with the |
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704 | 1042 | | rules promulgated by the State Boar d of Medical Licensure and |
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705 | 1043 | | Supervision or the State Board of O steopathic Examiners; |
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706 | 1044 | | 46. 47. “Supportive personnel” means technicians and auxil iary |
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707 | 1045 | | supportive persons who are regularly paid employees of a pharmacy |
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708 | 1046 | | who work and perform tasks in the pharmacy as authorized by Section |
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709 | 1047 | | 353.18A of this title; |
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710 | 1048 | | 47. 48. “Third-party logistics provider” including “virtual |
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711 | 1049 | | third-party logistics provider” means an entity that provides or |
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712 | 1050 | | coordinates warehousing, or other logistics services of a product in |
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713 | 1051 | | interstate commerce on behalf of a manufacturer, wholesale |
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714 | 1052 | | distributor, or dispenser of a product but does not t ake ownership |
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715 | 1053 | | of the product, nor have res ponsibility to direct the sale or |
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716 | 1054 | | disposition of the product. For the purposes of this paragraph, |
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717 | 1055 | | “third-party logistics provider” third-party logistics provider does |
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718 | 1056 | | not include shippers and the United States Postal Service; |
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719 | 1057 | | 48. 49. “Wholesale distributor ” including “virtual wholesale |
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720 | 1058 | | distributor” means a person other than a manufacturer, a |
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752 | 1114 | | 49. 50. “County jail” means a facility operated by a county for |
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753 | 1115 | | the physical detention and correction of persons charge d with, or |
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754 | 1116 | | convicted of, criminal o ffenses or ordinance violations or persons |
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755 | 1117 | | found guilty of civil or criminal contempt; |
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756 | 1118 | | 50. 51. “State correctional facility” means a facility or |
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757 | 1119 | | institution that houses a prisoner population under the jurisdiction |
---|
758 | 1120 | | of the Department of Corrections; |
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759 | 1121 | | 51. 52. “Unit dose package” means a package that contains a |
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760 | 1122 | | single dose drug with the name, strength, control number, and |
---|
761 | 1123 | | expiration date of that drug on the label; and |
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762 | 1124 | | 52. 53. “Unit of issue package” means a package that provides |
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763 | 1125 | | multiple doses of the same drug, but each drug is individually |
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764 | 1126 | | separated and includes the name, lot number, and expirat ion date. |
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765 | 1127 | | SECTION 3. This act shall become effective July 1, 2024. |
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766 | 1128 | | SECTION 4. It being immediately necessary for the prese rvation |
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767 | 1129 | | of the public peace, health or safety, an emergenc y is hereby |
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768 | 1130 | | declared to exist, by reason whereof this act shall t ake effect and |
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769 | 1131 | | be in full force from and after its passage and approval. |
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